In The Spotlight
VarmX, a Dutch, Leiden based biotech company focusing on the development of therapies in the field of hemostasis and thrombosis, announced the publication in Nature Communications of a ground breaking LUMC study(1) on modified human factor X as a safe and effective reversal agent for prevention and treatment of bleeding in patients taking factor Xa oral anticoagulants.
NeuroRX , Acute Suicidal Ideation and Behavior (ASIB) , NRX-100 (ketamine HCl) , NRX-100 (ketamine HCl) , NeuroRx, a clinical stage biopharmacompany developing the first oral therapy for Acute Suicidal Ideation and Behavior (ASIB), has been granted Fast Track status by the US Food and Drug Administration for its sequential therapy of NRX-100 (ketamine HCl) followed by NRX-101 (D-cycloserine + lurasidone). The company will shortly begin enrolling patients in a pivotal trial of this sequential therapy targeting patients who are admitted to Emergency Departments with ASIB in bipolar depression.
AstraZeneca and Takeda Pharmaceutical Company Limited announced that they have entered an agreement to jointly develop and commercialise MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).
Eisai Co., Ltd. has announced that the results of a subpopulation analysis of patients with hepatitis B virus (HBV) coinfection in a Phase III trial of its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: Lenvima / Kisplyx, "lenvatinib") versus sorafenib as a first-line treatment for unresectable HCC were presented for the first time during the 11th Annual Conference of the International Liver Cancer Association (ILCA) held in Seoul, South Korea.
Levicept Ltd., an asset-centric biotechnology company focused on the development of LEVI-04, a first-in-class treatment for chronic pain indications announces that it has commenced its Phase I trial of LEVI-04 in healthy volunteers and osteoarthritis patients at Hammersmith Medical Research, London UK.
RIBOXX PHARMACEUTICALS, a biotech company developing Toll-like-receptor (TLR) and RIG-I-like-Receptor (RLR) ligands, and ACCINOV, a pharmaceutical establishment for experimental drug product announced the successful industrial GMP manufacturing, including packaging and quality control of RIBOXXIM®, a novel and highly potent Toll-like Receptor 3 (TLR3)-ligand.
Recipharm, a leading contract development and manufacturing organisation (CDMO) and Kancera, a development company focused on cancer therapy, have signed a contract for the development and manufacture of the pharmaceutical candidate KAND567.
Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products announced it has entered into an exclusive agreement with US WorldMeds, LLC for the commercial manufacture of lofexidine.
Acasti Pharma Inc announced the achievement of a major corporate milestone by manufacturing the first cGMP batches of CaPre®, Acasti’s omega-3 pharmaceutical product candidate, produced with a proprietary and innovative continuous manufacturing process developed in partnership with CordenPharma.
A Dutch contract packaging organisation (CPO) has strengthened its bottle filling capacity with a major investment.
Intertek, a leading quality solutions provider to industries worldwide, has approved the ABB laboratory in Ratingen, Germany as the first Intertek SATELLITE™ Data Acceptance Program laboratory for ETL and ASTA.
According to new industry research more than half (54%) of industry professionals believe that the cost of implementing serialization is the greatest hurdle to compliance.
Gilead Sciences, Inc. and Kite Pharma, Inc announced today that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Kite for $180.00 per share in cash.
Oxford Genetics, a leader in innovative synthetic biology-based technologies for biologics discovery, development and delivery,has announced a £7.5 million investment into its operations in the US and the UK by Mercia Technologies PLC, an existing investor, and Invesco Perpetual.
The Mundipharma network of independent associated companies announced that it has acquired from CellAct the worldwide development, commercialization and manufacturing rights to CAP7.1.
CURE Pharmaceutical has developed innovative drug delivery technology in CureFilm, an oral film strip that dissolves in the mouth, allows for multiple active ingredients in one dosage, and features higher bioavailability.
In recent years the pharmaceutical industry has seen a significant change to the way its manufacturersand supply chains operate, due to the establishment of several serialization and track and trace regulations mandated globally.
Patient-centricity has become an important focus for drug developers and an essential element of clinical studies aimed at showing that a new therapy addresses real patient needs. How companies define patient-centric trials sometimes differ.
Aplagon Oy (“Aplagon”) and Cadila Pharmaceuticals Sweden AB today announced a development and commercialization agreement for Aplagon’s lead APAC product. APACs are proprietary, locally acting, potent antithrombotic products, which target blood vessel wall injury.
Worldwide Clinical Trials has been announced as a finalist for a second year in the 2017 “Best Contract Research Organization – Full Service Providers” category of the Scrip awards.
Shuwen Biotech announced today that it has received CE-IVD marking for its EGFR real time PCR detection kit allowing the company to market its kit in countries that recognize the designation.